Kelly Science, Engineering, Technology & Telecom ยท 2 days ago
Quality Assurance (QA) Supervisor
Rochester, MN
Full-time
Onsite
Mid, Senior Level
$90K/yr - $110K/yr
5+ years expKelly Science, Engineering, Technology & Telecom is a leading pharmaceutical organization seeking a Quality Assurance Supervisor. In this role, you will lead a QA team to ensure product excellence and regulatory compliance within a cGMP-regulated environment.
Staffing & Recruiting
Responsibilities
Lead, mentor, and develop a high-performing QA team, fostering a culture of accountability, compliance, and continuous improvement
Oversee QA training programs to ensure team proficiency in cGMP requirements and quality systems
Set performance objectives, provide coaching, and conduct evaluations to support team growth
Oversee investigations of deviations, CAPAs, and OOS results, ensuring timely and effective resolution
Make informed decisions on product quality and regulatory compliance, escalating risks as needed
Manage customer complaint processes to uphold product integrity
Review and approve SOPs, methods, batch records, reports, and protocols supporting cGMP activities
Support internal and external audits, regulatory inspections, and supplier audits, including documentation and response management
Assist in maintaining and enhancing the Supplier Management Program
Contribute to the ongoing development of the Quality Management System through SOP improvements, training, and process enhancements
Qualification
Required
Bachelor's degree in a scientific discipline
5+ years of Quality Assurance experience within the pharmaceutical industry
2+ years of leadership or supervisory experience
Strong knowledge of quality systems, deviation investigations, CAPA, risk assessments, and compliance standards
Experience supporting inspections and audit readiness
Excellent leadership, communication, and technical writing skills
Ability to independently manage multiple priorities and lead projects effectively
High attention to detail and strong problem-solving capabilities
Occasional travel for training or educational purposes
Ability to lift up to 50 pounds and perform standing/walking activities in a manufacturing environment
Adaptability to work in an environment with fumes, airborne particles, and moving machinery
Preferred
Familiarity with cGMP regulations, including ICH Q7 and 21 CFR Part 211
Experience with regulatory submission processes
Experience with software tools related to quality management
Previous exposure to manufacturing environments involving airborne particles, fumes, and moderate noise
Bachelor's degree in a scientific field
At least 5 years of QA experience in the pharmaceutical sector
Leadership experience in a regulated environment
Benefits
Medical
Dental
Vision
Telemedicine
Term life
Whole life
Accident insurance
Critical illness
A legal plan
Short-term disability
Retirement savings plan
Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
Transit spending account
Paid sick leave under the applicable state or local plan
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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